Patient-reported outcomes in coronary artery disease: the relationship between the standard, disease-specific set by the International Consortium for Health Outcomes Measurement (ICHOM) and the generic health-related quality of life instrument 15D.

BACKGROUND: Patient-reported outcome (PRO) instruments measure health gains, including changes in health-related quality of life (HRQoL). Previous studies have assessed the reliability and relationship of multiple HRQoL instruments in search of the optimal instrument for feasible measurement of PROs. Although the 15D instrument was shown to have the best sensitivity and construct validity among cardiac patients, it is unknown how well it captures relevant disease-specific information scores compared to instruments included in the International Consortium for Health Outcomes Measurement (ICHOM) standard set. The aim of this study was to investigate whether the disease-specific PRO instruments and a generic HRQoL instrument capture disease related symptoms in coronary artery disease (CAD) patients. METHODS: Health status and HRQoL were assessed with the instruments included in the ICHOM standard set: Seattle Angina Questionnaire short-form (SAQ-7), Rose Dyspnea Scale (RDS), two-item Patient Health Questionnaire (PHQ-2), and with the 15D HRQoL instrument at baseline and 1 year from the treatment in a university hospital setting. Spearman correlation and explanatory factor analysis were used to assess the relationship of baseline scores and 1-year change in scores of 297 patients. RESULTS: At baseline, the overall 15D score and SAQ-physical limitation (SAQ-PL), 15D "breathing" and SAQ-PL, as well as "breathing" and RDS showed moderately strong correlations. The factor interpreted to reflect "Breathing-related physical activity", based on high loadings of "breathing", RDS, SAQ-PL, "mobility", "vitality", and "usual activities", explained 19.2% of the total variance. Correlations between 1-year changes in scores were fair. The factor of "Breathing-related physical activity", with significant loading of RDS, SAQ-PL, "breathing, "usual activities", "vitality", "sexual activity", "mobility", and disease-specific quality of life explained 20.5% of the total variance in 1-year change in scores. The correlation of angina frequency measured by SAQ-7 and the 15D instrument was poor. CONCLUSIONS: The 15D detects dyspnea and depression similarly to RDS and PHQ-2 but not angina similarly to the SAQ-7. This may call for supplementing the 15D instrument with a disease-specific instrument when studying CAD patients.

Long-term clinical outcomes, health-related quality of life, and costs in different treatment modalities of stable coronary artery disease.

Aims: This study is a prospective, observational 8-year follow-up of 300 stable unselected coronary artery disease patients entering elective coronary angiography in 2002-03. Recorded were clinical outcomes, health-related quality of life (HRQoL), and secondary care costs after coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), or medical therapy (MT). Methods and results: HRQoL was measured by the 15D instrument at baseline, 6 months, and 8 years. Regression techniques with an adjustment for relevant baseline characteristics were used to compare the 8-year survival and change in HRQoL between the groups. At baseline, all groups had statistically significantly impaired HRQoL compared with age- and gender-standardized general population. Six months after invasive interventions the mean HRQoL score had improved in a statistically significant and clinically important manner. This improvement was maintained at 8 years as the HRQoL no longer differed from that of the general population, whereas MT patients were still worse off. However, after adjustment for baseline characteristics, the groups no longer differed regarding 8-year survival or change in HRQoL among survivors. Mean 8-year secondary care costs were without (with) adjustment for baseline characteristics: €17 498 (16 730) for CABG, €7245 (6920) for PCI, and €4514 (4580) for MT, respectively. Conclusion: When adjusted for baseline characteristics, no statistically significant differences were found between the patient groups in 8-year survival or change in HRQoL among survivors. The 8-year mean secondary care costs of CABG were over two-fold and almost four-fold, even after adjustment for baseline characteristics, compared with those of PCI and MT.

Attitudes to self-sampling of vaginal smear for human papilloma virus analysis among women not attending organized cytological screening.

BACKGROUND: The major problem with the cytological screening is the non-optimal participation rate among women invited for cervical smear collection. The aim of the present investigation was to examine the attitudes of the non-responding women to perform self-sampling of vaginal smear at home as a method to increase the coverage of the screening and to examine the prevalence of high-risk human papilloma virus (HPV) among the responding women. METHODS: From the database of the Department of Cytology, University Hospital of Uppsala 198 women, aged 35-55 years, who had not attended the organized gynaecological screening for over 6 years were identified. They were sent a letter of information about the study and one week later a self-sampling device aimed to collect vaginal smear. The vaginal smear of the women responding to the offer of self-sampling was analysed for high-risk HPV using Hybrid Capture 2 method or polymerase chain reaction amplification of HPV DNA. All women in the study also received a questionnaire in order to investigate their attitudes towards self-sampling as an alternative in the organized screening. RESULTS: Of the 198 women 15 women had to be excluded. Fifty-eight per cent of the women responded and collected vaginal smear at home and among them 7% were positive for high-risk HPV. The questionnaire revealed no significant difference of age, country of birth and occupation or marital status, on using self-sampling of vaginal smear at home. The attitudes among responding and non-responding women differed. The responding women who contributed by sampling vaginal smear were more positive to self-sampling of vaginal smear (p<0.01). CONCLUSIONS: Offering self-sampling of vaginal smear in women not attending the organized cytological screening increases the coverage and identifies an additional group of women with an increased risk to develop cervical cancer. The attitude towards self-sampling was mainly positive.

High prevalence of oncogenic human papilloma virus in women not attending organized cytological screening.

Since the introduction of organized cytological screening in Sweden, most women currently presenting with cervical cancer are those who have not attended the programme and who have no cytological screening history. The aims of this study were: (i) to measure the response rate among women not attending organized cytological screening who were offered a device for self-sampling a vaginal smear at home; (ii) to examine the prevalence of high-risk human papilloma virus (HPV) among women performing self-sampling. Women aged 35-50 years, who had not participated in organized cytological screening for more than 6 years, were offered the opportunity to collect vaginal samples at home using a self-sampling device (Qvintip). The material collected was analysed for high-risk HPV using the Hybrid Capture 2 method. Of 369 women included in the study, 179 (49%) ordered the self-sampling device and 117 (32%) performed self-sampling at home and sent the sample to our laboratory for analysis. The mean prevalence of high-risk HPV was 26% (30/117), 31% (25/80) in women aged 35-42 years and 14% (5/37) in women aged 43-50 years. There was no significant difference in the participation rate with regard to age. The prevalence of high-risk HPV in women not covered by organized screening was considerably higher than in the general population; therefore they may represent a category at high risk of cervical cancer. The study shows that the use of a disposable self-sampling device for HPV testing is a relevant method to increase the participation rate in countries with organized cytological screening.

Accuracy of HPV testing of vaginal smear obtained with a novel self-sampling device.

BACKGROUND: Most of women diagnosed as having cervical cancer have not participated in organized cytological screening. Aim. A study was conducted to evaluate the accuracy of human papilloma virus testing by self-collected vaginal samples in comparison to regular cytological screening. The agreement of hybrid capture 2 assay and polymerase chain reaction assay for detection of human papilloma virus DNA in self-collected vaginal samples and clinician-obtained cervical smears was investigated. METHOD: Forty-three women aged 23-58 years admitted for further examination due to previous positive cytology in the organized screening participated in self-collecting of vaginal samples with a novel self-sampling device. During the visit a clinician also collected a cervical smear using a cytobrush. The vaginal samples collected with the self-sampling device were analyzed for high-risk human papilloma virus with the hybrid capture 2 assay technique and the cervical smears were Pap-stained, examined cytologically and after that reanalyzed for human papilloma virus DNA using a polymerase chain reaction assay. RESULT: The vaginal samples were positive for high-risk human papilloma virus in 37% of the cases using hybrid capture 2 assay. Twelve of the 43 Pap smears showed positive cytology (ASCUS-CIN 3), of which 4 showed CIN 2-3. When polymerase chain reaction assay was performed, human papilloma virus DNA was detected in 40% of the glass slides. The agreement between cytology and the two human papilloma virus testing techniques was 67-74% (kappa 0.27-0.45) and the agreement between the two human papilloma virus tests was 70% (kappa 0.36). CONCLUSION: Testing for high-risk human papilloma virus can identify more women at risk of developing cervical cancer than cytology irrespective of the sampling method. Furthermore, offering a self-sampling device for collection of vaginal smear seems to be a useful screening tool for cervical cancer among women not responding to an invitation for smear sampling.